# K092744: Neonatal Ecg Electrode, M203KEN

- Pathway: 510(k) (Traditional)
- Applicant: R & D Medical Products, Inc.
- Decided: Dec 10, 2009 after 93 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011564 (2002). 2 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050443: Accu-Lead, Kentec Medical, Inc. (2005) Summary page 1.
- K011564: Neolead, Neotech Products, Inc. (2002)

## Most influential descendants
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own
- K152942: NuVasiveNVM5 System (2016), 13 descendants of its own
- K162313: NuVasive Next Generation NVM5 System (2017), 7 descendants of its own

## Indications for use
These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.

Source page: https://510kreport.com/device/K092744
Methodology: https://510kreport.com/methodology